Image guided catheters and methods of use

ABSTRACT

An interventional medical device is provided that incorporates a forward-directed ultrasound imaging system integrated into a single device. The medical device can be in the form of sheaths, catheters, and interventional devices, particularly those suitable for minimally invasive procedures in the human or other mammalian body. The imaging system comprises one or more small ultrasound transducers that can be permanently integrated into the device or integrated into an interchangeable ultrasound transducer that can be inserted into and removed from the device to customize the device for a particular use. An ultrasound system can be provided in the device either alone or in combination with fiber optic imaging to provide a range of imaging and therapeutic capabilities of the device.

CROSS-REFERENCE

This application claims priority to provisional U.S. Application Ser.No. 60/851,451 filed Oct. 12, 2006, the entire disclosure of which ishereby incorporated by reference into the present application.

TECHNICAL FIELD

Embodiments of the illustrated and disclosed aspects and features relateto minimally invasive interventional medical devices having integratedultrasound imaging systems.

BACKGROUND

Ultrasound operates by creating an image from sound in threesteps—producing a sound wave, receiving echoes, and interpreting thoseechoes to create an image.

Ultrasound has many uses in medical applications. For example,ultrasound is routinely used during pregnancy to provide images of thefetus in the womb. Generally, a water-based gel is applied to thepatient's skin, and a hand-held probe, called a transducer, is placeddirectly on and moved over the patient. The probe typically contains apiezoelectric element that vibrates when a current is applied. Inultrasound devices, a sound wave is typically produced by creatingshort, strong vibrational pulses using a piezoelectric transducer. Thesound wave is reflected from tissues and structures and returns an echo,which vibrates the transducer elements and turns the vibration intoelectrical pulses. The electrical pulses are then sent to an ultrasoundscanner where they are transformed into a digital image.

While general-purpose ultrasound machines may be used for most imagingpurposes, certain procedures require specialized apparatus. For example,in a pelvic ultrasound, organs of the pelvic region can be imaged usingeither external or internal ultrasound. In contrast, echocardiography,which is used in cardiac procedures, can require specialized machines totake into account the dynamic nature of the heart.

Ultrasound has advantages over other imaging methods such as magneticresonance imaging (MRI) and computed tomography (CT). For example,ultrasound is a relatively inexpensive compared to those techniques.Ultrasound also is capable of imaging muscle and soft tissue very well,can delineate interfaces between solid and fluid filled spaces, andshows the structure of organs. Ultrasound renders live images and can beused to view the operation of organs in real time. Ultrasound has noknown long-term side effects and generally causes little to nodiscomfort to a patient. Further, ultrasound equipment is widelyavailable, flexible, and portable.

However, ultrasound does have some drawbacks. When used on obesepatients, image quality is compromised as the overlying adipose tissuescatters the sound and the sound waves are required to travel greaterdepths, resulting in signal weakening on transmission and reflectionback to the transducer. Even in non-obese patients, depth penetration islimited, thereby making it difficult to image structures located deepwithin the body. Further, ultrasound has trouble penetrating bone and,thus, for example, ultrasound imaging of the brain is limited.Ultrasound also does not perform well when there is gas present (as inthe gastrointestinal tract and lungs). Still further, a highly skilledand experienced ultrasound operator is necessary to obtain qualityimages. These drawbacks do not, however, limit the usefulness ofultrasound as a medical diagnostic and treatment tool.

The use of ultrasonic apparatus for imaging areas of the human body,either alone or in combination with other instruments, is known, forexample, for guiding therapeutic instruments through a catheter to afield of view within a human body. For example, ultrasound devices havebeen combined with catheters for insertion into a body, usually througha vein or artery, to reach a part of the human body for examination ortreatment. Such devices are commonly known in the art as “imagingcatheters.”

For example, U.S. Pat. No. 5,704,361 to Seward et al. discloses avolumetric image ultrasound transducer underfluid catheter system. Forexample, FIGS. 2-9 and 11-12 of Seward et al. and their attendantdescription suggest specific methods of intervention for imagingpurposes in the vicinity of a human heart. To reach such an area ofinterest within a human body, an ultrasound imaging and hemodynamiccatheter may be advanced via the superior vena cava to a tricuspid valveannulus. A distal end of a cylindrical body includes a guide wire accessport and a guide wire provides a means of assuring that the catheterreaches a target for imaging. A surgical tool may be fed through thecatheter to the area imaged.

U.S. Pat. No. 6,572,551 to Smith et al. provides another example of animaging catheter. Tools such as a suction device, guide wire, or anablation electrode, may be incorporated in an exemplary catheteraccording to Smith et al.

U.S. Pat. No. 5,967,984 to Chu et al. describes an ultrasound imagingcatheter with a cutting element which may be an electrode wire or alaser fiber. FIGS. 1 and 2 of Chu et al. also describe a balloon 14 anda means to inflate the balloon. The balloon, for example, may beutilized to dilate a vessel having strictures imaged via the imagingcatheter.

Other imaging catheters are known. For example, U.S. Pat. No. 6,162,179to Moore teaches bending (using a pull wire) an acoustic window into aknown and repeatable arc for improved three dimensional imaging. U.S.Pat. No. 6,306,097 to Park et al. discloses an intravascular ultrasoundimaging catheter whereby a first lumen provides access for an ultrasoundimaging catheter and a second lumen provides a working port for a tool.U.S. Pat. No. 5,505,088 to Chandraratna et al. teaches using a 200 MHztransducer in an ultrasonic microscope combined with a catheter as adelivery means for the microscope to provide imaging of myocardialtissue. According to Chandraratna et al., lower frequency ultrasoundtransducers can provide deeper penetration in the tissue but do notprovide the image quality provided by higher frequencies.

All the above-cited references are incorporated by reference as to anydescription which may be deemed essential to an understanding ofillustrated and discussed aspects and embodiments of devices and methodsherein.

SUMMARY

This summary is intended to introduce, in simplified form, a selectionof concepts that are further described in the Detailed Description. Thissummary is not intended to identify key or essential features of theclaimed subject matter, nor is it intended to be used as an aid indetermining the scope of the claimed subject matter.

A device in accordance with one or more aspects described herein caninclude ultrasound imaging, optical imaging through the use of fiberoptics, or a combination of both, to provide a wide range of imagingcapabilities coupled with one or more diagnostic, therapeutic, orinterventional capabilities. In one or more embodiments according toaspects herein, an interventional ultrasound device may include anelongate body having a proximal end and a distal end, one or more lumenextending through the elongate body, one or more ultrasound transducersembedded in the elongate body near the distal end, and one or more otherimaging channels such as a fiber optic channel.

Illustrative aspects described herein include a minimally invasiveinterventional medical device that can provide ultrasound imagingcoupled together with one or more interventional capabilities. Thefrequencies present in a sound wave output by such a device can rangebetween 20 KHz and 300 MHz. Frequencies in the lower range, for example,below 1 MHz, and particularly in the 100-200 KHz range, can be used, forexample, to provide heat therapy or to treat conditions such as bloodclots. Frequencies above 1 MHz can be used to provide imaging. Forexample, frequencies in the 25-30 MHz range can be used to image organssuch as the eye or can be used to provide imaging of small animals.Higher frequencies, for example, frequencies in the 100-200 MHz range,can be used to provide higher-resolution imaging, sometimes known ashigh-frequency ultrasound microscopy.

An embodiment of a device in accordance with one or more aspects andfeatures described herein can include an ultrasonic imaging catheterhaving one or more forward-directed transducers that can be integrateddirectly into a distal end of an elongate body so as to provide a directforward view of the tissue being accessed. Another embodiment of adevice in accordance with one or more aspects and features describedherein can include a minimally invasive device comprising an ultrasonicimaging catheter having an introducer needle and one or moreforward-directed transducers integrated into a single elongate body sothat the needle and the imaging catheter can be introduced into a bodysubstantially simultaneously so that the needle and the path taken bythe needle can be viewed as it travels through the body. An alternativeembodiment of a device in accordance with aspects described herein canhave one or more ultrasonic transducers located along one or more sidesof the elongate body, either with or without a forward-directedtransducer.

The ultrasound features of the device can serve to guide and facilitatesurgical procedures performed with the device. For example, a medicalprofessional such as a surgeon can receive direct vision of a targetedarea in real time.

A wide variety of other interventional elements also can be incorporatedinto such a device.

For example, in some embodiments of a device in accordance with one ormore aspects and features described herein, an ultrasound imagingtransducer can be combined with an interventional catheter having anintroducer needle so that the catheter can be inserted under ultrasoundimaging guidance directly into the target site. For example, thecatheter can be inserted directly through the chest wall into the heartwithout having to make entry through another means such as through ablood vessel in a human leg. Once at the target location, the needle canbe removed and replaced with another instrument such as a biopsy needleor the entire assembly can be removed after a guide wire is introducedso that other instruments can be delivered to the target site.

In another embodiment in accordance with one or more aspects herein, amedical device is provided that can comprise one or more ultrasoundtransducers coupled or associated with a syringe element for delivery orwithdrawal of fluids at a treatment site. An exemplary syringe that canbe used is a needle assembly such as is described in U.S. Pat. No.6,592,559 to Pakter et al., which can deliver multiple needles tomultiple sites within the body.

According to other aspects, at the proximal end of such a device, ananchoring portion is provided for anchoring the device to a human bodyonce the device is image-guided to the diagnosis or treatment site.

According to aspects herein, the elongate body of such a device may beformed from one or more of a variety of materials such as silicone,Teflon, polyurethane, PVC, and/or elastomeric hydrogel. According tosome aspects, the elongate body may be cylindrical in shape and mayinclude, for example, a catheter or vascular sheath.

These and other aspects will be discussed with reference to thedrawings, a brief description of which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-described aspects and embodiments of devices and proceduresand other features and advantages can be appreciated and understood byreference to the following detailed description when considered inconnection with the accompanying drawings wherein:

FIGS. 1A-1D present views of one embodiment of a minimally invasivedevice in accordance with aspects described herein. FIG. 1A provides aside view of a device in accordance with aspects described herein, andalso includes six cross-sectional views along the length of the depictedembodiment. FIG. 1B provides a cross-sectional view of a deviceaccording to the embodiment illustrated in FIG. 1A. FIG. 1C providesfurther detail of the distal end of the device of FIG. 1A. FIG. 1Dprovides a further view of a minimally invasive device having aforward-directed ultrasonic transducer and an introducer needle.

FIGS. 2A-2E show additional side views of the device of FIG. 1. FIG. 2Ashows the device of FIG. 1 without a needle housed within the devicelumen. FIGS. 2B-2E show side and cross-sectional views of embodiments ofdevices having various types of distal ends and apertures for multiplelumens in accordance with one or more aspects described herein.

FIGS. 3A and 3B depict additional views of a patient end and an operatorend of an imaging device in accordance with one or more aspectsdescribed herein,

FIGS. 4A and 4B show side and cross-sectional views of a device havingmultiple lumens in accordance with one or more aspects described herein.

FIGS. 5A-5E show views of an ultrasound transducer for use in aminimally invasive interventional device in accordance with one or moreaspects described herein. FIG. 5A depicts one embodiment of aforward-projecting small ultrasound transducer according to one or moreaspects described herein. FIG. 5B depicts arrangements of transducerelements that can be made in different housing configurations. FIGS. 5Cand 5D depict design options for a flat-faced and a round-faced housing,respectively, for a forward-projecting ultrasound transducer for use ina device in accordance with aspects described herein.

FIG. 6 depicts a device having both ultrasound and fiber optic imagingin accordance with one or more aspects described herein.

FIGS. 7A and 7B depict embodiments of a device having a MEMS positionmanipulator in accordance with one or more aspects described herein.

FIGS. 8A-8D depict embodiments of a biopsy instrument that can be usedin a minimally invasive device in accordance with one or more aspectsdescribed herein.

FIGS. 9A and 9B show views of a retrieval instrument that can be used ina minimally invasive device in accordance with one or more aspectsdescribed herein.

FIGS. 10A-10C depict aspects of an imaging catheter in accordance withone or more aspects herein wherein an ultrasound transducer housing canbe configured to be interchangeable with an outer sheath. FIG. 10Adepicts aspects of a hollow outer catheter having a port configured tohouse an imaging device such as an ultrasound transducer. FIG. 10Bdepicts an embodiment of an ultrasound transducer having a ridge alongits length so that it may be inserted into a housing such as is shown inFIG. 10A. FIG. 10C depicts a cross-sectional view of an exemplarycatheter body having a channel into which an ultrasound transducer witha ridge as shown in FIG. 10B is inserted.

FIGS. 11A and 11B depict an embodiment of an imaging catheter whereinboth a needle and an ultrasound transducer are disposed within a singleneedle/imaging channel.

FIGS. 12A-12F depict aspects of an imaging catheter having a singlechannel for both a needle and an ultrasound transducer. FIGS. 12A and12B depict such an imaging catheter in combination with a syringeelement at a proximal end. FIG. 12C depicts aspects of such a catheterwherein a guide wire can be inserted to permit an additional device tobe directed to a target site. FIG. 12D depicts an embodiment of a devicein accordance with aspects herein wherein a guide wire is passed througha sheath. FIGS. 12E and 12F depict aspects wherein the transducer andneedle are removed from the single channel to permit use of a syringe,for example, to deliver or remove fluids from the target site.

FIGS. 13A-13D embodiments of an outer shell for use with an imagingcatheter in accordance with one or more aspects described herein. FIG.13A depicts an embodiment of an outer shell for use with a transducerhaving a handle portion in accordance with aspects herein. FIG. 13Bdepicts an embodiment of an outer shell for use with a transducerwithout a handle portion in accordance with aspects herein.

FIGS. 14A-14E depict embodiments of a locking mechanism that can be usedwith an outer shell of an imaging catheter in accordance with one ormore aspects described herein.

FIGS. 15A and 15B depict embodiments of a portion of an outer shellhaving a locking mechanism in accordance with one or more aspectsdescribed herein.

FIGS. 16A and 16B depict embodiments of an imaging catheter having anintroducer needle integrated into a single device with an ultrasoundtransducer in accordance with one or more aspects described herein.

FIG. 17 illustrates aspects of an exemplary dual-balloon cardiacprocedure that can be performed with an interventional medical deviceconfigured in accordance with one or more aspects described herein.

DETAILED DESCRIPTION

The aspects summarized above can be embodied in various forms. Thefollowing description shows, by way of illustration, combinations andconfigurations in which the aspects can be practiced. It is understoodthat the described aspects and/or embodiments are merely examples. It isalso understood that other aspects and/or embodiments can be utilized,and that structural and functional modifications can be made, withoutdeparting from the scope of the present disclosure.

Minimally invasive procedures provide physicians with access to internalorgans and structures via a small number of incisions in the patient'sbody. Minimally invasive procedures are generally preferable over openprocedures because they require only small incisions, thus reducingtrauma to the body, lessening recovery time, and reducing costs. Themedical instruments used in performing such procedures are generallysimilar to those used in open surgical procedures except they include anextension such as a tubular extension between the end of the instrumententering the surgical field (i.e., the operable end of the tool,instrument or device) and the portion gripped by the surgeon.

Typically, minimally invasive procedures involve up to five incisions upto one inch in length. The treatment area is then accessed by insertingone or more cannulas or sleeves through the incisions to provide entryports through which instruments are passed. Alternatively, access to thetreatment area can sometimes be obtained using a natural bodily openingsuch as the throat or rectum. In procedures using this approach, acannula or sleeve is inserted into the bodily opening and surgicalinstruments are passed to the treatment site, either through thecannula/sleeve or directly through the bodily opening.

While minimally invasive procedures provide numerous advantages overopen procedures, they generally do not provide a physician with a directview of the targeted sites. Further, many parts of the anatomy arerather complex and/or small and thus require particular precision anddelicate handling. It is therefore desirable to provide precise imagingtechniques for use during minimally invasive procedures.

In general, the illustrated embodiments and aspects provide a devicethat couples an imaging system and a delivery system and/or minimallyinvasive interventional device. The delivery system can include, forexample, delivery of materials to or from a target site or delivery ofinstruments and devices to a target site.

In accordance with aspects described herein, an ultrasound imagingcatheter can comprise one or more small ultrasound transducersintegrated into an elongate body, either as forward-directed transducersfor direct, head-on imaging or combined with one or more side-directedtransducers which can provide additional imaging or other ultrasoundapplications to the patient. In addition, such ultrasound imaging canalso be combined with optical imaging through the use of one or morefiber optic bundles disposed though the elongate body.

An imaging system in accordance with aspects and features describedherein can guide and facilitate many different procedures, therebysignificantly assisting in the access of and performance of procedureson organs, structures and cavities within the body, particularly duringminimally invasive procedures. The described devices and methods arecompatible with all surgical and diagnostic devices and will allowbedside emergency procedures. Ultrasound provides particular benefitsbecause it is biologically safe and uses non-radiating energy to providedetailed anatomic and, in some cases, functional images. The imagesgenerated by devices described herein can provide a user with directvision within the body in real time. Further, ultrasound provides a userwith visualization of structures as well as within and beyondstructures.

In certain embodiments, the device can comprise an ultrasound imagingcatheter that incorporates one or more variable frequency ultrasoundtransducers operating at one or more frequencies within the frequencyrange of from 20 KHZ to 200 MHz. The various frequencies of theultrasound transducer can be used for different purposes and providedifferent beneficial results. Frequencies in the lower range, forexample, below 1 MHz, and particularly in the 100-200 KHz range, can beused, for example, to provide heat therapy or to treat conditions suchas blood clots. Frequencies above 1 MHz can be used to provide imaging.For example, frequencies in the 25-30 MHz range can be used to imageorgans such as the eye or can be used to provide imaging of smallanimals. Higher frequencies, for example, frequencies in the 100-200 MHzrange, can be used to provide higher-resolution imaging, sometimes knownas high-frequency ultrasound microscopy.

Devices and methods such as are described herein are suitable for use ina variety of medical procedures. In certain embodiments, the device cancomprise conventional catheters including, for example, biopsycatheters, ablation catheters, and mapping catheters, in combinationwith the novel imaging aspects described herein. In other embodiments,the device can comprise one or more interventional devices (e.g.syringe, forceps, biopsy instruments, clamps, retractors, etc.) that maybe compatible with a catheter such as a biopsy catheter, ablationcatheter, mapping catheter, or other form of sheath. In someembodiments, the device can also be compatible with instrument such asvideoscopes and delivery needles such as those used for stem celltherapy. In still other embodiments, the devices can be compatible withfiber optics such as those used for vision therapy.

The devices and methods of various embodiments of an imaging cathetersuch as those illustrated in FIGS. 1-17 and described herein can be usedin various minimally invasive surgical procedures and in otherdiagnostic and therapeutic applications. One skilled in the art willappreciate that the aspects and embodiments of an imaging catheter asdescribed herein, although advantageously suited for such procedures onhumans, can have other uses, such as for veterinary procedures and openmedical techniques as well as minimally invasive procedures in humans.Further, while the devices of the present invention are described withparticular reference to catheters, this shall not be construed aslimiting the devices to the these embodiments, as it is contemplated andthus within the scope of the illustrated devices to adapt the devicesdescribed herein so as to be in the form of any type of minimallyinvasive device (e.g. syringes, sheaths, wires, forceps, biopsyinstruments, clamps, retractors, etc.).

Further, while certain devices, systems and methods are described hereinwith particular reference to pericardial access devices, systems, andmethods, this shall not be construed as limiting, as it is contemplatedto adapt the devices, systems and methods described herein so as to beused in any of a number of procedures, including, but not limited to:various cardiovascular procedures; general micro-surgery; biopsy, drugand device delivery; vascular procedures; urology; thoracic procedures;otorhinolaryngology (ear, nose and throat); orthopedic procedures;neurosurgery; gynecologic procedures; gastroenterologic and generalprocedures; colon and rectal procedures; pericardiocentesis;thoracentesis; ascites tap; ventricular lead placements; and electricaland electromechanical mapping of the heart. As such, it is contemplatedthat the specific design parameters, other characteristics set forthhereinafter, and methods in relation thereto can be modified to provideappropriate dimensions and geometries as required to perform such othertechniques. For example, the length and diameter of the device as hereindescribed is adapted to suit the particular conditions for a givenprocedure. Thus, the disclosure to follow should is illustrative onlyand should not be construed as limiting in any configuration of a deviceas described herein.

Referring now to the various figures of the drawing wherein likereference characters refer to like parts, FIGS. 1-4, 6, 10-12, 13, and16 depict various views of embodiments of a minimally invasive device100 according to one or more aspects described herein. Devices forperforming minimally invasive procedures, including sheaths (e.g.,vascular sheaths), catheters, and interventional devices (e.g. forceps,biopsy instruments, clamps, retractors, etc.) are conventional invarious forms as described above and, thus, although described and shownwith reference to preferred embodiments, the general features (e.g.size, shape, materials) of the a device 100 may be in accordance withconventional devices.

FIG. 1A depicts a side view of a device 100 in accordance with one ormore aspects and features described herein. Device 100 can be used toprovide a three-dimensional mapping system solely using an incorporatedultrasound system or in connection with other imaging modalities such ascomputed tomography, magnetic resonance, videoscopy. When the device isin the form of a catheter or sheath, this will allow stereotactic andremote/robotic operation of devices inserted and manipulated throughdevice 100. In such a system, an imaging modality (ultrasound, CT orMRI) can be used to generate a three-dimensional image. The device caninteractively use the generated images to be directed either manually orthrough an automated or semi-automated process for deployment to atarget area displayed in the three-dimensional image. Device 100 can beused in connection with an ultrasound display system (B mode image or 3Dimage) that interfaces with the device to produce and display theimages.

In an embodiment of a device described herein, as shown in FIG. 1A, andalso as shown in FIGS. 16A and 16B, device 100 can be in the form of acatheter and comprises an elongate body 200 having an outer shell 224and a proximal end 202 and a distal end 204. In accordance withconventional practice, the term “proximal end” is used herein todescribe the specified end closest to the medical personnel manipulatingthe device, and the term “distal end” is used to describe the oppositeend of the device that is placed near or within a patient). The elongatebody 200 can be fabricated of any conventional materials used in formingcatheters, sheaths, and interventional devices. For example, when in theform of a catheter, the outer shell 224 of elongate body 200, forexample, as shown in FIGS. 13A and 13B, can be fabricated of, forexample, silicone, Teflon, polyurethane, PVC, and elastomeric hydrogel(AQUAVENE). In certain embodiments, the elongate body 200 can becylindrical in shape; in other embodiments, elongate body 200 can be asquared cylinder, oval cylinder or other shape as may be appropriate fora particular application or use.

The dimensions of the elongate body 200 are not particularly limited andcan vary depending on the ultimate use of device 100, the insertionpoint, and the distance to the target area from the insertion point. Thediameter of the elongate body 200 can be affected by the size of ananatomical structure in which it is to be inserted. For example,elongate body 200 can be longer and more slender for deep abdominalstructures such as the kidneys or pelvic structures such as the ovariesor uterus, or can be shorter and wider for delivery of devices into moreshallow structures such as a joint, muscle, the liver, or the heart. Thediameter of the elongate body 200 can also be affected by the desiredsize of the incision through which device 100 is inserted and which mustsubsequently be closed or by the purpose for which it is used. Forexample, the diameter of the elongate body 200 can be smaller foraspiration of fluids from a target site or larger if additional ports ordevice delivery are desired.

For example, when device 100 is in the form of a vascular sheath, theouter diameter can vary depending on the targeted blood vessel throughwhich the elongate body 200 is inserted. In an embodiment, device 100can be in the form of vascular sheaths used during cardiac proceduresand can be inserted through a blood vessel in the upper thigh or,alternatively, can be inserted through a blood vessel in the arm. Inanother embodiment, device 100 can be inserted by anesthetizing an areathe patient's upper thigh and inserting the elongate body 200 through ablood vessel in the upper thigh and towards the heart. In thisembodiment, the elongate body 200 can have a length sufficient totraverse this pathway. In an additional embodiment, device 100 can havean introducer needle 208 integrated therein, which can enable device 100to penetrate directly into the chest wall of a patient for direct accessto the heart without the need for access through the vascular system.

Device 100 can also be in the form of a sheath used during alaparoscopic procedure, and in such a case, the elongate body 200 cangenerally have an outer diameter in accordance with conventionallaparoscopic sheaths and will have a length that provides access to thetarget site.

Further, the device can be used as a minimally invasive conduit from theskin surface to the target site to allow passages of catheters, guidewires, and instruments through elongate body 200, can the elongate body200 can be sized to allow these various instruments to be passedtherethrough.

In an exemplary embodiment described in more detail herein, device 100can be in the form of a catheter that can be introduced through thechest to access various internal structures using minimally invasivetechniques. As such, the elongate body 200 can have an outer diameterranging from about 1 F to 15 F (wherein 1 F=0.33 mm) and a lengthranging from about 1″ to 20″. Specific lengths and diameters can beprovided based on the insertion site of the catheter, the distance tothe desired target site(s), and the space required for insertion of oneor more interventional devices through the elongate body 200.

In other embodiments, device 100 can be in the form of anyinterventional device that can be, for example, inserted through asheath or catheter to access various internal structures using minimallyinvasive techniques. As such, the elongate body 200 can have an outerdiameter sized so as to fit within conventional sheaths or catheters,and a length suitable to access the desired target site(s) through thesheaths or catheters.

In some embodiments, for example as shown in FIG. 1A, a Luer lock 222can be provided at a proximal end 202 of the elongate body member 200.Luer lock 222 can be used to connect the device to, for example, aTouhey or a syringe (not shown). In some embodiments, a hemostatic valveand/or silicone pinch valve or water tight valve (not shown) can belocated at the proximal end 202 of the elongate body 200 to preventleakage of materials, such as blood and body fluids, out of device 100.In some embodiments, a side-arm (not shown) in fluid communication withone or more lumen 206 may also be located near the proximal end 202 ofthe elongate body 200. An aspiration device or syringe can be connectedto the side arm, if desired, to aspirate blood clot and other materialsthrough the lumen 206 or to inject water, saline, contrast agent orsimilar material may be injected through device 100 to a target site.

As shown in FIG. 1A and FIG. 1B, device 100 also can be provided withone or more anchoring portions 218 at the proximal end 202 of theelongate body member 200. The anchoring portion 218 can assist inmaintaining device 100 in proper position during use and can prevent orinhibit unwanted motion of the device. If desired, one or more sutures(not shown) can be used with the anchoring portion 218 for suturing thedevice to the skin to provide additional stability of the device duringuse. For example, the anchoring portion 218 can be provided with one ormore suture holes 220. In some embodiments, anchoring portion 218 can beslidably movable along a length of the elongate body member 200 and canlock into place, for example by locking into one of a plurality ofdetents (not shown) along the length of the elongate body to provideanchoring of the catheter or sheath at different depths of penetrationinto the body.

One or more guide wires (not shown) may further be incorporated into theelongate body 200 for steerable guidance of device 100 to the targetarea.

In certain embodiments, device 100 can be in the form of a catheter orsheath and the elongate body 200 is provided with one or more lumen 206extending therethrough. See FIGS. 1A-1D and 2A-2E. Depending on the useof the lumen 206, the design and configuration can vary. For example, insome embodiments as described further herein, a central wire lumen 206 acan be provided through which a needle 208 is insertable as shown inFIGS. 1A, 1C, and 1D. The needle can be used, for example, to puncturevarious target sites to allow direct access to the part of the bodybeing treated and inject or withdraw materials from the target site.Central wire lumen 206 a can be sized to accommodate the size of theneedle 208. For example, for an 8-30 gauge needle 208, lumen 206 can beat least 8-30 gauge so as to accommodate a needle of such a size.

As shown in FIG. 2C, in some embodiments, device 100 can also beprovided with one or more interventional device lumen 206 b, either withor without the presence of a central wire lumen 206 a, through which oneor more interventional devices can be inserted and manipulated. It canbe readily appreciated that these lumen 206 b also can be sized so as toallow for insertion and manipulation of the interventional devicestherethrough.

As shown in FIG. 2C, in some embodiments, device 100 is provided withone or more injection/aspiration lumen 206 c through which materials canbe injected and removed. For example, emboli, blood clots, and othermaterials can be evacuated from a blood vessel using an aspirationtechnique, and agents, such as medicaments, anticoagulants, and contrastmedia may be injected into the treatment site using, for example, asyringe in connection with the lumen 206 c. As such, these lumen 206 ccan be sized in accordance with conventional injection/aspiration lumen206 c.

In other embodiments, for example, as shown in FIG. 2E, a guidewirelumen 206 d can be provided through which a guidewire is inserted forsteerable guidance of device 100 into the desired site. In a mannersimilar to that noted above with respect to other lumen 206, lumen 206 dcan be sized to accommodate conventional guidewires.

In some embodiments, such as is shown in FIGS. 2B, 2C, 2D, and 2E,device 100 can be provided with any combination of these lumen 206 a,206 b, 206 c, 206 d. In addition, in some embodiments, lumen 206 a, 206b, 206 c, 206 d can be used interchangeably to carry therapeutic,guidance, or other devices in device 100. For example, three lumen 206can be provided and can be used to insert, for example, a fiber opticendoscope, a biopsy needle, and a therapy delivery needle. In otherembodiments, up to five lumen 206 can be provided, each havingindependent entry ports (not shown) for insertion and deployment of upto 5 independent medical devices and/or injection/aspiration through thedevice, either simultaneously or individually.

As shown in FIGS. 1A, 1C-1D, 2A-2E, and FIG. 10A, the elongate bodymember 200 can be tapered at the distal end 204. This shape isparticularly suitable for use in, for example, accessing the heartthrough the chest through the pericardium. However, the distal end canbe provided with other shapes such as, for example, rounded, square,beveled/angled, and pigtailed. In addition, in some embodiments, the tipcan be angled or beveled at an angle of 10°, at 20°, at 30°, at 40°, at50°, at 60°, at 70°, or at 90° or any angle in between these angles.

Device 100 can incorporate an imaging system that provides a user withvisualization within the body during a procedure. The imaging system isparticularly useful in minimally invasive procedures wherein directvisualization of the target site is unavailable. In some embodiments ofa device in accordance with one or more aspects described herein, forexample, as shown in FIGS. 1A, 3A, and 7A, 10A, 11A, 11B, and 12A-12E,the imaging system can be in the form of an ultrasound system comprisingone or more ultrasound transducers and an imaging channel. In otherembodiments, for example, as shown in FIG. 6, an imaging system caninclude an ultrasound imaging system combined with a fiber optic imagingsystem to provide additional imaging capabilities.

Ultrasound and fiber optic systems are well-known and, thus, althoughthese systems may be described and shown with reference to a particularembodiment, the general features and components of an ultrasound systemor fiber optic system that can be used in a device as described hereinmay be in accordance with conventional features for such systems.

As shown in FIGS. 1A, 1C, 1D, 3A, 6, 7A, 7B, 11A, 12A-12E, 16A, and 16B,the imaging system can include one or more ultrasound transducers 210that are positioned on the elongate body 200. In one or more embodimentsof an imaging interventional device in accordance with aspects andfeatures described herein, one or more transducers 210 can be positionedat a distal end 204 of the elongate body 200 to provide imaging to auser as the device is guided to a treatment site. In addition,transducers 210 can also provide imaging functionality such that whenthe device is properly inserted and positioned at the target site, oneor more transducers 210 can provide images of the target site.

In general, a single transducer 210 is operated at any given time. Insome embodiments, a plurality of transducers 210, having differentspecifications as desired, can be provided on a device at variouslocations to provide a user with various imaging capabilities. Forexample, front-facing transducers as described in more detail below withrespect to FIG. 5 can be provided either alone or in combination withside-facing transducers to provide a user with the capability to viewstructures in front of the device as well as to the sides of the device.Further, different sized and types of transducers can provide a userwith various imaging capabilities (e.g. different sized views, more orless precision, etc.).

As described in more detail with respect to FIG. 5, transducers 210 canbe of a size and composition in accordance with conventionaltransducers. For example, in some embodiments, the transducers 210 cancomprise natural piezoelectric materials such as quartz, topaz, ortourmaline group minerals or can comprise man-made materials such as PZTceramics or piezoelectric polymers such as Polyvinylidene fluoride(PVDF). Transducers 210 can also be of any suitable size, with such sizebeing limited by the desired size of the elongate body 200 and the usewhich is being made of the ultrasound, i.e., for imaging or therapeuticpurposes. In addition, as transducer size is decreased, the quality ofthe image provided also generally decreases. Thus, the smallest sizedtransducer that provides adequate imaging is generally used so as tominimize the required size required of the elongate body 200. Forexample a 2-3 mm×2 mm transducer will generally be used with an elongatebody of 5-6 Fr. In certain embodiments, the transducers 210 have amaximum dimension of 5 mm, in other embodiments 4 mm, in otherembodiments 3 mm, and in other embodiments 2 mm.

The transducers 210 can generally be mounted or attached to the elongatebody 200 by providing one or more mounting aperture (not shown) in whichthe transducers 210 can be fit and held by a friction. Various adhesivescan further be used to hold the transducers 210 in place.

Conducting elements 212, which can control one or more transducers 210,can extend from the transducers 210 to the proximal end 202 of theelongate body 200 and can connect to an external system (ultrasoundscanner) such as a gray scale color two-dimensional Doppler ultrasoundsystem. Conducting elements 212 can cause the transducer to emit thesound waves and transmit sound waves reflected from tissues andstructures to an ultrasound scanner where they can be transformed into adigital image. The conducting elements 212 can extend through theelongate body member 200 within one or more imaging channels 214. Theimaging channels 214 can be provided in various sizes and, in exemplaryembodiments, can range in size from 8-30 gauge.

As shown in, for example, FIG. 1A, FIG. 13A, 15A, 16A, an ultrasoundtransducer that can be used in device 100 can have a handle that can beheld by an operator to facilitate manipulation of the device. As shownin FIG. 1A, the handle can be a center-mounted handle that extendsoutward from a longitudinal axis of the device. In an alternativeembodiment, for example, as shown in FIG. 16A, the handle can be offsetfrom a longitudinal axis of the device so that the portion of the devicehousing the transducer does not interfere with the portion of the devicehousing other instruments such as introducer needle, biopsy needle,guide wire, etc.

FIG. 3A depicts a further view of a patient end of a minimally invasiveimaging catheter and access instrument 200 in accordance with one ormore aspects described herein. As seen in FIG. 3A, an embodiment of anaccess instrument as described herein can include a transducer element210 and ultrasound imaging channel 214 integrated into a singleinstrument. In the embodiment shown in FIG. 3A, the access instrumentincludes an introducer needle 208 that is disposed to be within imagingzone 301 created by transducer element 210. To reduce ultrasounddeflection during use of the device, as seen in FIG. 3A as well as inFIG. 1A, the imaging system can be provided with matching layers 216disposed, for example, adjacent the front face of transducer element210. Matching layers 216 can facilitate the matching of an impedancedifferential that may exist between the high impedance transducerelements and a low impedance patient. The structure of matching layers216 can generally be in accordance with conventional matching layers andgenerally can include a matching layer front face and a matching layerrear face, and can optionally include a pocket with matching materialthat can reduce ultrasound deflection. Suitable matching layer materialscan include, for example, plastic materials such as polysulfone orREXOLITE® (a thermoset material produced by crosslinking polystyrenewith divinyl benzene, available from C-LEC Plastics, Inc., Beverly,N.J.).

The imaging system may further include a backing layer (not shown) inaccordance with conventional backing layers. The backing layers cangenerally be coupled to the rear face of the transducers 210 andfunction to attenuate acoustic energy that emerges from the rear face ofthe transducers 210. Generally, such backing layers can have a frontface and a rear face, and can be fabricated of acoustic damping materialthat possesses high acoustic losses.

FIG. 3B shows an exemplary view of from the viewpoint of an operator endof a combined imaging and interventional device in accordance with oneor more aspects described herein, for example, a device such as isillustrated in FIG. 3A. FIG. 3B shows an anchoring portion 218 of adevice 100 in accordance with one or more aspects described herein.Looking towards the proximal end of the device, an operator can see twochannels in the device, for example, an imaging channel 214 and achannel 208 that can accommodate an introducer needle 208, either aloneor in conjunction with a Luer lock 222 such as discussed above withrespect to FIG. 1A.

As seen in FIG. 4A, the distal end 202 of the body member 200 can beprovided with one or more side apertures 224 in connection with the oneor more lumen 206. Alternatively, as seen in FIG. 4B, the distal end ofthe body member 200 can be provided with one or more end-on apertures224 to accommodate one or more lumen 206 l. The one or more of theapertures 224 can be provided with the same or varying diameters. Theapertures 224, in connection with one or more lumen 206, can be used forinjection and withdrawal of materials and insertion of variousinstruments (needles, guide wires, biopsy devices, etc.) In someembodiments, each aperture 224 can be associated with its own lumen 206,while in other embodiments, one or more apertures 224 can share a one ormore common lumen 206.

As noted above, embodiments of an imaging interventional device inaccordance with one or more aspects described herein can have one ormore ultrasound transducers as an integral part of the device to provideimaging capabilities to the user. FIGS. 5A-5D depict various aspects ofan ultrasound transducer that can be used in a device in accordance withaspects described herein.

As shown in FIG. 5A, a forward projecting small ultrasound transducersuch as transducer 210 shown, for example, in FIG. 1A and FIG. 3A, cancomprise a cylindrical housing 501 and a plurality of transducerelements 502. In some embodiments of a device as described herein, theplurality of transducer elements can comprise a phased array transducerknown in the art, while in other embodiments, the plurality oftransducer elements can comprise a linear array transducer.

In an exemplary embodiment of a forward projecting small ultrasoundtransducer shown in FIG. 5A, the plurality of ultrasound transducerelements can be a series of rectangular elements having an approximateexemplary length of 3-4 mm and arranged in a parallel row for anexemplary total height of approximately 3 mm on a face of a transducerwhose total diameter, including the housing, is less than 5 mm. As notedabove, these dimensions are exemplary only, and should not be taken asproviding an upper or lower limit of the dimensionality of an ultrasoundtransducer as described herein.

FIGS. 5B and 5C depict two exemplary embodiments of housing designoptions for a small ultrasound transducer such as transducer 210 inaccordance with aspects described herein. As shown in FIGS. 5B and 5C, aplurality of small ultrasound transducer elements can be placed towardsa front/imaging end 503 of a small ultrasound transducer to provideforward-directed imaging capabilities for an interventional device asdescribed herein. As seen in FIGS. 5B and 5C, a housing 501 for anultrasound transducer component that can be integrated into aninterventional device as described herein can have either a flat face asshown in FIG. 5B or a rounded face as shown in FIG. 5C.

FIGS. 5D and 5E depict additional aspects of a forward-directed smallultrasound transducer such as transducer 210 for use in a device asdescribed herein. A forward-directed small ultrasound transducer can beeither cylindrical, with a round face, as shown in FIG. 5D, or moreoblong in shape, with an ellipsoid face, as shown in FIG. 5E. As shownin FIG. 5D, an exemplary cylindrical transducer in accordance with oneor more aspects described herein can have a round face having a diameterof 4-5 mm and a plurality of small transducer elements 502 arranged in arow along the central axis of the face. Similarly, as seen in FIG. 5E,an exemplary oblong transducer can have an ellipsoid face having a majoraxis length of approximately 5 mm, a minor axis length of approximately4 mm, and a plurality of small transducer elements 502 arranged in a rowalong one axis of the ellipsoid. It should be noted that although in theembodiment illustrated in FIG. 5E, the elements are arranged along themajor axis, in practice the small transducer elements can be arranged oneither the major or the minor axis as may be desirable for a particularuse or functionality. It should also be noted that described dimensionsare merely exemplary and are not intended to be either minimum ormaximum dimensions, of a transducer housing that can be used in a deviceas described herein.

As noted above, FIG. 6 depicts an embodiment of device 100 havingcombined ultrasound and fiber optic elements. As shown in FIG. 6, adevice as described herein can have an ultrasound transducer 210 and anultrasound imaging channel 214 which provides an ultrasound imaging area601, and can also have a fiber optic bundle 602 which provides anoptical imaging area 603. For example, ultrasound transducer 210 can befocused to provide imaging of one portion of the target area while fiberoptic bundle 602 can be focused to provide imaging of another portion ofthe target area. The combination of fiber optic capability withultrasound can provide beneficial additional functionality to a deviceas described herein. For example, ultrasound imaging can penetrate atarget to provide a view of an interior of the target area but cannotprovide a view of the surface of the target. In contrast, fiber opticcannot penetrate the target but can provide a view of the surface. Thus,having a dual ultrasound/fiber optic imaging capability can allow anoperator to have both an interior and a surface view, giving an operatormore information, for example, regarding the target site and thetreatment to be applied.

In addition, as noted above, ultrasound transducer 210 can be configuredto operate at different frequencies to provide different levels ofimaging or therapeutic capabilities, and these capabilities can becombined with the optical capabilities of fiber optic bundle 602 toprovide a wide range of imaging and/or therapeutic functions. Forexample, ultrasound transducer 210 operating a frequency above 1 MHz,and in particular, in the 100-200 MHz range, can provide good imaging,but only for a very short distance, and thus combining such ahigh-frequency transducer 210 with a fiber optic bundle 602 can providegood imaging at a greater distance. Alternatively, ultrasound transducer210 operating at frequencies below 1 MHz can provide therapeutictreatment such as heat therapy or ablation, and thus combining alow-frequency transducer 210 with a fiber optic bundle 602 can provideboth imaging and therapy in one device.

In some embodiments, device 100 can be steerable and externallycontrolled by the operator. For example, the distal end 204 of theelongate body 200 can be manipulated by controls located on a portion ofdevice 100 positioned outside of the body during use. Alternatively, insome embodiments, one or more Micro-Electro-Mechanical Systems (MEMS)devices can be incorporated into de vice 100 to allow an operator tocontrol aspects of the device. MEMS systems can include, for example,mechanical elements (beams, cantilevers, diaphragms, valves, plates, andswitches), sensors, actuators, and electronics. For example, as shown inFIG. 7A, a MEMS position manipulator 701 can be mounted on device 100 ata distal portion of device 100 to control a position of transducer 210to, for example, standard position 702, Position A 702 a or Position B702 b. In other embodiments, one or more MEMS devices can be provided tofunction as tiny sensors and actuators. For example, MEMS can beincorporated in the device for measuring and monitoring pressure in thestomach or other organs in which the catheter is inserted, and formeasuring and monitoring blood pressure when performing cardiaccatheterization.

In another embodiment, for example, as shown in FIG. 7B, a MEMSmanipulator lead fixation device 703 can be provided to permit anoperator to remotely access a portion of a device within a patient'sbody. For example, MEMS manipulator 703 can be used to screw in a leadfor a pacemaker implanted in a patient. Alternatively, MEMS manipulator703 can be used to operate a biopsy needle or to manipulate asuture-application device within a patient. It should be noted thatthese uses are exemplary only and that a device having a MEMSmanipulator as described herein can be used to access or manipulate anydevice in a body or for any other suitable purpose.

In accordance with aspects described herein, a device 100 having abiopsy instrument such as that depicted in FIGS. 8A-8D. In such anembodiment, device 100 can be adapted for use in biopsy proceduresincluding but not limited to myocardial biopsy, brain biopsy, musclebiopsy, lung biopsy, liver biopsy, kidney biopsy, uterine and ovarianbiopsy, esophageal biopsy, stomach biopsy, intestinal biopsy, tumorbiopsy (anywhere), targeted biopsy of potentially abnormal zones in anyof the above items (e.g., ultrasound guided biopsy of an abnormal areain the liver or kidney with the present catheter will allow access tothe abnormal area, identification of abnormal zones by deploying theultrasound and biopsy instrument to the specific area of interest). Assuch, device 100 can, in some cases, be in the form of a catheter orsheath-like device that is insertable through small incisions in thebody. The sheath-like device could include one or more lumen 214 throughwhich a biopsy tool could be inserted. Device 100 in the form of asheath could, thus, be provided along its length, as set forth above,with one or more ultrasound transducers 210 along with the othercomponents required to provide ultrasound imaging using the transducers210.

In another case, device 100 could itself be a biopsy tool (either aminimally invasive biopsy tool that is insertable through a sheath or abiopsy tool that is directly insertable within the body). In thisembodiment, for example, as shown in FIGS. 8A-8D, the distal portion ofthe biopsy tool could include the mechanism for obtaining a biopsy(tissue sample) as well as one or more transducers 210, along with theother components required to provide ultrasound imaging using thetransducers 210 as discussed herein. As shown in FIGS. 8A and 8B, abiopsy blade 801 in an open position can be disposed, for example, in alumen 206 of device 100. As seen in FIGS. 8A and 8C, a needle withbiopsy blade 801 in open position can be inserted into the body and thenclosed as shown in FIGS. 8B and 8D to remove a portion of tissue fortesting.

In another embodiment, such as is shown in FIGS. 9A and 9B, device 100can include a retrieval instrument in combination with a bioptome orother custom instrument 903. As is known in the art, a bioptome cancomprise a specialized biopsy catheter for use in cardiac applications,particularly a catheter with a special end designed for obtainingendomyocardial biopsy samples. In use, a bioptome can be threadedthrough a guiding catheter such as an imaging catheter in the form ofdevice 100 to the right ventricle, where it can snip small tissuesamples from the septal wall for pathologic examination. In other uses,a bioptome tip device can be used to monitor heart transplantationpatients for early signs of tissue rejection. In use, as seen in FIGS.9A and 9B, a retrieval instrument having a bioptome 903 can be in closedposition 901 at a distal end and closed position 904 at a proximal endto assist in inserting the instrument into the area of interest, andthen can be placed into an open position 902 at the distal end so thatthe desired tissue can be retrieved for examination or testing.

FIG. 10A-10C depict an additional embodiment of device 100 in accordancewith aspects and features described herein. It can be appreciated thatconfiguration of device 100 can be customizable as may be appropriatefor a particular therapeutic application or for use at a particularsite. For example, device 100 can be long and slender or shorter andwider, depending on the use to which it is put. In addition, it may bedesirable to place device 100 at a target site under imaging guidance,for example, using one or more ultrasound transducers 210, and thenremove the transducer and insert instead a different transducer 210 foruse at the treatment site. For example, a transducer at one frequencymay provide one type of imaging capability such as lower-frequency,lower-resolution ultrasound imaging at greater depth, which may beuseful to place the device, whereas higher-frequency, higher-resolutionultrasound imaging at a shorter distance may be more desirable once thedevice is in place and treatment begins. Alternatively, ultrasound at aneven lower-frequency than that used to guide the device to the targetsite may be desirable for therapeutic uses, such as to provide heat totissue or to permit ablation of tissue from the target site.

In another embodiment, the second, replacement transducer can have otherdifferent properties than the first one. For example, the secondtransducer can be of different dimensions, in length, in diameter, orboth, than the first transducer, as may be appropriate for use at thetreatment site. Alternatively, the second transducer can be made of adifferent material having different properties. For example, the secondtransducer can be of a smaller diameter and/or more flexible than thefirst as may be appropriate to permit the device to be placed at thetarget site.

In addition, it can be appreciated that a device 100 can become damagedor contaminated by body fluids during use and therefore must bediscarded after the procedure.

Consequently, it can be advantageous to provide a device having anultrasound transducer that can be interchangeably placed within orremoved from an outer sheath as may be desirable. In the case where thedevice 100 is discarded after the procedure, this can enable the outersheath to be discarded while the transducer can be reused after beingsterilized.

In the embodiment depicted in FIGS. 10A-10C, elongate body in the formof a catheter 200 can be provided without an ultrasound transducerelement but instead with an empty imaging channel 1001 into which atransducer element can be placed to provide an imaging catheter asdescribed in more detail above. Such an imaging catheter can be combinedwith the other aspects such as an introducer needle or one or more otherinterventional or therapeutic devices, for example, through needlechannel/lumen 206 shown in FIG. 10A. In this embodiment, as shown inFIG. 10B, a transducer 1003 can be provided that can be configured tofit within imaging channel 1001 shown in FIG. 10A. In some embodiments,transducer 1003 can also have a protruding ridge 1004 along the lengththereof and imaging channel 1001 can have a corresponding groove so thatridge 1004 can fit within the groove to provide a secure placement oftransducer 1003 within imaging channel 1001. Such a configuration isshown in FIG. 1C, which shows a cross-sectional view where transducer1003 having ridge 1004 is placed within catheter 200 having a needlechannel/lumen 206.

FIGS. 11A and 11B depict an embodiment of an imaging catheter whereinboth a needle and an ultrasound transducer, for example, in the form ofa combined needle/transducer assembly, are disposed within a singleneedle/imaging channel as opposed to being in parallel channels asshown, for example, in FIG. 3A. As shown in FIG. 11A, an embodiment ofan imaging catheter can include an outer sheath 200 as described above,having a single channel into which can be disposed both an introducerneedle 208 and a transducer element 210 having a transducer housing 501and transducer connection 1105. These elements may collectively bereferred to herein as a needle assembly. As shown in FIG. 11A, such aconfiguration can provide an imaging zone 301 which can be used, forexample, to guide the device to the target site after having it isinserted into the body using needle 208. One or more buffers 1102 can beprovided in the channel to prevent transducer element 210 from cominginto direct contact with, and thus possibly being damaged by, needle208. In addition, a device as shown in FIG. 11A can be provided with aLuer lock hub 1103 on the sheath, alone or in conjunction with a Luerlock connection 1104 on needle 208, for example, for a syringeattachment (not shown).

In addition, one or more channels 1101 can be provided around theneedle/imaging channel to provide access for a guide wire or to providea channel for the delivery or withdrawal of fluids. In an embodiment ofa device in accordance with aspects herein, channels 1101 can be used toprovide fluids such as a saline solution to assist in the delivery ofthe device to the target site or to provide fluids such as therapeuticdrugs to the target site. Alternatively, channels 1101 can be used tohouse a dye or other imaging aid within the catheter body itself so thatthe device can be viewed by external imaging means. For example, as isknown in the art, a saline solution appears cloudy when viewed byexternal imaging means and thus having a saline solution disposed in oneor more of channels 1011 can assist an operator to view the device as ittravels through the body or once it reaches the target site.

FIG. 11B depicts cross-sections along the length of a device as shown inFIG. 11A. For brevity and clarity in the Figure, only additionalelements at each stage along the length of the device are denoted byreference numbers. As shown in FIG. 11B, cross section 1 shows needle208. Cross section 2 shows needle 208 and an outer ring denotingcatheter/sheath 200. At cross-section 3, there is shown needle 208 andouter sheath 200, plus channels 1101 described above with reference toFIG. 11A. Cross-section 4 shows all the elements shown in cross-section3, plus a face of a buffer 1102 described above with reference to FIG.11A. Cross-section 5, which is taken on the other side of buffer 1102does not show a face of a buffer 1102 or needle 208 but instead shows aface of a transducer element 210 along with an outer ring depictingouter sheath 200 and channels 1101 described above. At cross-section 6,there is shown transducer housing 501, which houses transducerconnection 1105, with channels 1101 and outer sheath 200. Cross-section7 depicts the device at the level of Luer lock hub 1103, and shows anouter ring denoting Luer lock connection on the outer sheath. Inaccordance with one or more aspects described herein, Luer lock hub isat an operator end of the catheter/sheath 200 and can be used todirectly connect the device to a syringe after needle 208 is removed.Also shown are connector channels 1101 and transducer cable connection1105, which can exit the assembly on the side through a water-tightport. The final cross-section shown in FIG. 11B, cross-section 8,depicts a Luer lock connection 1104 end of the assembly shown in FIG.11A.

As shown in FIGS. 12A and 12B, in accordance with one or more aspectsdescribed herein, a syringe 1201 can be attached at the proximal endthereof, for example, by means of a Luer lock connection 1104. In oneuse, syringe 1201 can provide leverage and transmit force and torque toassist the needle in advancing through tissue to the target site. Inaddition, as described above, because channels 1103 also exit thecatheter/sheath 200 at the proximal end, the syringe can be used todeliver liquids such as anesthetic material, saline solution, imagingdye, or drugs to the front end of the needle by means of channels 1103.Similarly, as shown in FIG. 12B, if needle 208 is advanced into afluid-filled cavity, the fluid contents can be evacuated by suctionapplied to a plunger of syringe 1201.

As shown in FIGS. 12C and 12D, if it is desirable that one or moreadditional devices be delivered to the target site, syringe 1201 can bedisconnected from the catheter via Luer lock connection 1104 then thesyringe is disconnected, a guide wire 1202 can be introduced throughchannel 1103 and out of the front end of the needle into the hollow orsolid structure at the target location. In an exemplary embodiment,needle 208 can then be withdrawn, leaving guide wire 1202 in place suchthat the distal (patient) end of guide wire 1202 is retained in thetarget location. Another device such as a catheter or sheath 1203 asshown in FIG. 12D can then be threaded over this guide wire to thetarget location.

In an alternative embodiment as shown in FIGS. 12E and 12F, if no guidewire is needed and only fluid evacuation or delivery is necessary, thenthe sheath is advanced under vision such that the tip of catheter/sheath200 is in the desired target location. In an exemplary embodiment, thesheath has a needle assembly as described above inserted into an openingextending through the length thereof. As shown in FIG. 12E, once thecatheter reaches the target site, the needle assembly can be withdrawn,leaving the tip of the sheath in place. Syringe 1201 can then beattached to Luer lock connection 1103, and fluid can be drained from ordelivered into the target location.

FIGS. 13A and 13B show two embodiments of an outer shell 224 that can beused for an integrated imaging and interventional device 100 inaccordance with one or more aspects and features described herein. Asnoted above, an outer shell 224 of device 100 can be fabricated ofmaterials such as silicone, Teflon, polyurethane, PVC, and elastomerichydrogel (AQUAVENE). In an exemplary embodiment, an outer shell 224 asshown in FIGS. 13A and 13B can be configured to provide an imagingchannel 1001 that can accommodate an ultrasound transducer and a needlechannel 206 that can accommodate a needle to allow entry into aparticular anatomic location.

In an exemplary embodiment, imaging channel 1001 can consist of twoportions, one towards a distal end of the device and the other towards aproximal end. In accordance with one or more aspects described herein,the distal portion of imaging channel 1001 can be fabricated of asofter, pliable plastic or other material while the proximal portion canbe fabricated of a harder, more rigid material to prevent damage to thetransducer handle and keep its cable connections secure. Needle channel206 can be fabricated completely out of a softer, pliable plastic orother similar material, except for a hub 1303 at the operator end, forexample, as shown in FIGS. 13A-13D, which can be made of harder plastic.Hub 1303 can have a Luer lock or a straight connection to other devicesor, for example, a guide wire at the proximal end. As shown in FIGS. 13Cand 13D, in an exemplary embodiment, hub 1303 can have an overhangingedge all around needle channel 206 except for the region abutting thehandle chamber 1301 in the case where the transducer has a handle orimaging channel 1001 in the case where the transducer does not have ahandle.

In certain embodiments, an outer shell 224 for device 100 can have a capor other locking component 1302 for placement over a proximal end of thehousing to secure the transducer position within imaging channel 1001 sothat it does not rotate or slide out of position during use. Someexemplary configurations of cap or locking component 1302 are shown inFIGS. 14A-14E. FIG. 14A shows a screw-type cap, wherein cap 1402 canscrew into a screw mount 1401. An alternative embodiment of a cap isshown in FIG. 14B, which includes a cap portion 1404 that can cover anopening 1403 in handle chamber 1301 shown in FIG. 13A. As shown in FIG.14C, cap 1404 can lock into place to cover opening 1403 and secure thetransducer. In the alternative embodiment shown in FIG. 14D, lid 1404can be rotated around pivot point 1405 close over opening 1403. As shownin FIG. 14E, lid 1404 can be closed over opening 1403 in imaging channel214 either with or without the presence of ultrasound transducer element210 being secured within.

FIGS. 15A and 15B depict embodiments of an opening in the outer housingto accommodate an ultrasound transducer cable used in a device accordingto aspects and features described herein. 15A depicts an embodimentwherein the outer shell is configured to accommodate an ultrasoundtransducer having an offset handle as described above. In the embodimentdepicted in FIG. 15A, the transducer handle can reside in handle chamber1301 with the ultrasound transducer in imaging channel 1001 secured bylocking element lid 1404, and the cable 1503 for the ultrasoundtransducer can extend out of a cable side port 1502 in handle chamber1301. The embodiment depicted in FIG. 15B is similar, but is configuredto house an ultrasound transducer element not having an offset handle.In this embodiment, as in the embodiment shown in FIG. 15A, theultrasound transducer can reside in imaging channel 1001 secured bylocking element lid 1404, with transducer cable 1503 extending out ofcable side port 1502 in imaging channel 1001. In either embodiment, useof a side port for an ultrasound transducer cable will allow the cableto exit the device without impeding the locking mechanism or otherwisereducing the secure position of the transducer within imaging channel1001.

FIGS. 16A and 16B depict embodiments of a complete device assembly inaccordance with one or more aspects and features described herein. Asshown in FIG. 16A, a device 100 in accordance with aspects herein caninclude an outer shell 224, for example, as described above with respectto FIG. 13A, having an ultrasound transducer 210 disposed within animaging channel 1001 and a needle 208 disposed within a needle channel206. In the embodiment of device 100 shown in FIG. 16A, transducer 210has an offset handle 1602 disposed within handle chamber 1301 and issecured within imaging channel 1001 by means of lid 1404. Needle channel206 has a needle channel hub 1303 that can abut a needle hub 1601, forexample, to provide a smooth transition area between needle channel 206and a needle hub 1601 at a proximate end of needle 208. Cable 1503extends from a port in handle chamber 1301, for example, as describedabove with respect to FIG. 15A.

FIG. 16B similarly depicts an embodiment of device 100 according toaspects described herein, in a case where transducer 210 does not havean offset handle 1602. In the embodiment shown in FIG. 16B, device 100can include an outer shell 224 having an ultrasound transducer 210disposed within an imaging channel 1001 and a needle 208 disposed withina needle channel 206. Transducer 210 is secured within imaging channel1001 by means of lid 1404 and has cable 1503 extending from a port inimaging channel 1001, for example, as described above with respect toFIG. 15B. As in the embodiment shown in FIG. 16A, needle channel 206 hasa needle channel hub 1303 that can abut a needle hub 1601, for example,to provide a smooth transition area between needle channel 206 and aneedle hub 1601 at a proximate end of needle 208.

FIG. 17 depicts an embodiment of an exemplary cardiac procedure that canbe performed using a device 100 as described herein. This procedure isdescribed only to give an example of an advantageous use that can bemade of a device having one or more of the features described herein,and is not intended to be in any way limiting of the type or scope ofprocedures for which a device as described herein can be used. Thisexemplary procedure involves the use of device 100 to insert and deploytwo balloons within a patient's pericardium to anchor the device to thepericardial wall so that additional interventional or therapeuticinstruments can be guided into the pericardium so that the patient canbe treated. Thus, in the embodiment shown in FIG. 17, a distal balloon232 b and a proximal balloon 232 a can be disposed within elongate body200. In an exemplary procedure, the device can be inserted into thechest, for example by use of an introducer needle integrated therein,and guided, for example by use of an integrated ultrasound transducer,to the pericardium. As shown in Step 1, the pericardial wall 240 can bepierced, for example, by the needle, so that the portion of the devicehaving distal balloon 232 b extends beyond the pericardial wall into thepericardium itself. At step 2, distal balloon 232 b can then beinflated, either by a saline solution or with another solution, so thatit fits against the interior pericardial wall of the patient. Oncedistal balloon 232 b is inflated, the elongate body 200 can be pulledtowards the operator so that balloon 232 b fits snugly against thepericardial wall, and at step 3 proximal balloon 232 a can be inflatedso that the elongate body 200 is secured in place within the chest. Inan alternative embodiment of such a procedure, one or more of balloons232 a and 232 b can be inflated using a solution bearing a contrastagent so that the device can be readily seen by MRI, CT scan or otherexternal imaging means. More detail regarding this exemplary procedureand other procedures which can be performed using a device employing oneor more aspects or features described herein is set forth in the U.S.Patent Application entitled “Image Guided Catheter Having DeployableBalloons and Pericardial Access Procedure” by Theodore Abraham, theinventor hereof, which is being filed concurrently with the presentapplication and which is hereby incorporated by reference herein.

Device 100 in accordance with one or more aspects described herein canhave many different embodiments for many different uses within the scopeand spirit of the present disclosure. Device 100 can be in the form of acatheter or sheath that provides entry into these various body spaces,thus allowing therapy delivery, intervention, placement of devices anddiagnostics. Device 100 can also be in the form of interventionaldevices for use in procedures within these spaces. Such catheters,sheaths, and devices are well known, and, thus, the general features ofdevice 100 for these embodiments can be in accordance with conventionaldevices.

In addition, when provided with one or more integrated transducers 210and other components required to provide ultrasound imaging as describedherein, device 100 can be used in a wide variety of procedures which canbe made substantially safer and easier through the combination ofimaging aspects with therapeutic aspects of the device.

In some embodiments, device 100 can be used to provide access vascularstructures including arteries, veins, lymphatics, and to other hollowstructures such as the gastrointestinal tract, genitourinary tract, andthe respiratory system. As such, the device can be in the form of, forexample, a vascular sheath. Such sheaths are well known, and, thus, thegeneral features of device 100 for these embodiments can be inaccordance with conventional devices. Device 100 could further includeone or more transducers 210, along with other components used to provideultrasound imaging using the transducers 210 as discussed herein.

In other embodiments, device 100 can be used in procedures in variousbody spaces such as the pleural peritoneal space, pericardial space,perisphinal space, pelvis, and cerebrospinal space. For example, thedevice can be adapted for use in paracentesis, biopsy of any intraabdominal or intrapelvic organ, prostate biopsy, biopsy of tumors orotherwise suspected abnormal structures within the pelvis and abdomen,diagnosis of endometriosis, treatment by chemicals, cells, bio-agents,physical energy (e.g., cryo, radiofrequency, heat, laser) of anypathology within the pelvis and abdomen, visualization and applicationof therapy within the genitourinary tract, and drainage of abnormal ornormal collection of fluid in actual or potential space in the abdomen,pelvis or genitourinary tract. In other embodiments, device 100 can bein the form of a catheter which can be used to drain fluid from apatient's gall bladder or any other hollow or solid organ in theabdomen.

Other procedures that can be performed using device 100 includeprocedures relating to diagnosis and treatment of infertility, includingfollowing a woman's ovum to determine an appropriate time for harvest,harvesting the ovum, and assisting in or performing the delivery of thefertilized egg to the uterus.

In some embodiments, device 100 can be designed for use in cardiac orvascular procedures and for accessing various targets. For example,device 100 can be designed to provide access to various structures suchas the coronary sinus and other cardiac venous structures. Exemplaryprocedures that can be performed using device 100 can include:epicardial biopsy; electronic mapping (endocardial or epicardial);electromechanical mapping (endocardial or epicardial); endocardial orepicardial ablation using any form of energy; cannulation or delivery ofcatheters, pacing leads, and interventional devices; and mapping andaccess to the fossa ovalis and patent foramen ovale to enable crossingthe atrial septum and allowing transvenous access to the left side ofthe heart; pericardiocentesis; left ventricular lead placement; deliveryof therapy (e.g., drugs, stem cells, laser therapy, or ultrasoundenergy); epicardial coronary artery bypass; valve repair and placement,delivery of cardiac shape modifying devices (e.g., ACORN® or MYOSPLINT®devices); myocardial scar reconstruction; ventricular reconstruction;ventricular assist device placement; and the treatment by chemicals,cells, bio-agents, physical energy (e.g., cryo, radiofrequency, heat,laser) of any pathology within the pericardial space or myocardium orintracardiac. As such, device 100 can, in some cases, be in the form ofa sheath-like device that is insertable through, for example, anincision in the patient's upper thigh and through a blood vessel all theway up to the heart. In such embodiments, guidewire can be providedwithin the device to guide the device to the target area. In otherembodiments, for example as described herein with reference to, forexample, FIGS. 1A, 1C, 1D, 3A, 3B, 6, and 11A the device can be insertedthrough the pericardial space through the use of an introducer needleintegrated therein. In either case, device 100 could have one or moreultrasound transducers 210 disposed along its length to provideultrasound imaging using the transducers 210.

In other embodiments, device 100 can be in the form of a device that isused in performing a cardiac procedure such as a biopsy instrument or aninstrument for valve repair. In this case, device 100 can be providedwith one or more transducers 210, along with the other componentsrequired to provide ultrasound imaging using the transducers 210 asdiscussed herein.

In other embodiments, device 100 can be in the form of devices for usein performing procedures on the musculo-skeletal system and foraccessing the musculoskeletal system. For example, device 100 can beused for treatment by chemicals, cells, bio-agents, or physical energy(cryo, radiofrequency, heat, laser) of any pathology within the jointcavity, joint components, or muscle and bone; visualization andapplication of therapy involving muscle, bone, and joint components,including a joint cavity; and drainage of abnormal or normal collectionof fluid in actual or potential space in the muscle, bone, or jointcomponents. In these embodiments, device 100 can be in the form of acatheter or sheath that provides access to the musculo-skeletal system,thus allowing therapy delivery, intervention, placement of devices anddiagnostics. Device 100 can also be in the form of interventionaldevices for use in procedures on the musculo-skeletal system. Suchcatheters, sheaths, and devices are well known, and, thus, the generalfeatures of device 100 for these embodiments can be in accordance withconventional devices. Device 100 would further include one or moretransducers 210, along with the other components required to provideultrasound imaging using the transducers 210 as discussed herein.

In some embodiments, device 100 can be in the form of devices for use inprocedures on the brain and nervous system and for accessing the brainand nervous system. For example, such devices can be used for thetreatment by chemicals, cells, bioagents, or physical energy (cryo,radiofrequency, heat, laser) of any pathology within the cranium andspinal and peri-spinal space including the vasculature contained within;visualization and application of therapy within the cranium, spinal, andperi-spinal space and all contained vasculature; drainage of abnormal ornormal collection of fluid in actual or potential space in the cranium,spinal, and peri-spinal space and all contained vasculature; and fortranscatheter delivery of interventional devices such as aneurysm clips,hematologic treatments, and any other drug or non drug therapy, eitherdirectly or via the vasculature or via any other hollow structure withinthe cranium, spinal, and peri-spinal space and all containedvasculature. In these embodiments, device 100 can be in the form of acatheter or sheath that provides access to the brain and system, thusallowing therapy delivery, intervention, placement of devices anddiagnostics.

Device 100 can further be adapted for use in procedures on the nasalpassages, sinuses, and pharynx and for accessing the nasal passages,sinuses, and pharynx. In these embodiments, device 100 can be in theform of a catheter or sheath that provides access to a desired site ofthe nasal passages, sinuses, and pharynx, thus allowing therapydelivery, intervention, placement of devices and diagnostics. Device 100can also be in the form of interventional devices for use in procedureson the nasal passages, sinuses, and pharynx (e.g., devices for therapydelivery, intervention, placement of devices and diagnostics). Suchcatheters, sheaths, and devices are well known, and, thus, the generalfeatures of device 100 for these embodiments can be in accordance withconventional devices. Device 100 would further include one or moretransducers 210, along with the other components required to provideultrasound imaging using the transducers 210 as discussed herein.

Device 100 can further be in the form of devices used to treat andaddress chronic problems and, as such, can be delivered and lodged inbody cavities, organs, or other anatomic locations for long termmonitoring or anatomy or function or dynamics including hemodynamics. Inthese examples, the device can be in the form of a catheter or sheath orother conventional chronic treatment or monitoring device that can belodged at a desired site. Device 100 would further include one or moretransducers 210, along with the other components required to provideultrasound imaging using the transducers 210 as discussed herein.

In some embodiments, the present device 100 can further be integratedwith other non-ultrasound imaging modalities including infrared, laser,optical coherence, fiber optic instruments including, but not limited toendoscopic mapping. For example, the body member 200 can further beprovided with a fiber optic lumen through which an optical fiber isinsertable.

The devices 100 can be used to perform any variety of medical proceduresincluding those set forth herein. The general features of theseprocedures is in accordance with conventional procedures and furthermake use of the integrated imaging system to provide visualization whileaccessing and performing procedures at the target site.

Access to other organs, structures, and spaces can be performed insimilar fashion with appropriate procedural modifications specific forthe particular organs, structures or spaces.

All documents mentioned herein are incorporated by reference herein asto any description which may be deemed essential to an understanding ofillustrated and discussed aspects and embodiments of devices and methodsherein.

Although the devices and methods discussed above and primarilyillustrated and described herein provide instruments that also can beadapted for performing minimally invasive diagnostic or therapeuticprocedures on humans, it will be appreciated by those skilled in the artthat such instruments and methods also are adaptable for use in othersurgical procedures as well as in performing various veterinarysurgeries. Further, while several preferred embodiments have beendescribed using specific terms, such description is for illustrativepurposes only, and it is to be understood that changes and variationsmay be made without departing from the spirit or scope of the followingclaims.

What is claimed is:
 1. A device configured to be used in minimallyinvasive medical procedures, comprising: an elongate body having noexterior delivery catheter or sheath, the elongate body configured tofacilitate entry of a catheter through skin tissue of a human body, theelongate body having proximal and distal ends, said elongate body havinga tapered tip at the distal end being configured to be directly insertedinto a target site within the human body during use of the device andhaving at least one longitudinal lumen extending along a longitudinalaxis thereof; a first imaging element disposed in one of said at leastone longitudinal lumen, said at least one longitudinal lumen having aproximal and a distal end, said first imaging element including a firstultrasound transducer being located at an outer periphery of the taperedtip of the elongate body at the distal end of the at least onelongitudinal lumen, said first ultrasound transducer configured toprovide a forward-directed imaging zone from the distal end to includethe tapered tip of the elongate body, a distal tip of the tapered tip ofthe elongate body being a most distal portion of the elongate body andbeing forward of the first ultrasound transducer, the first ultrasoundtransducer being configured for forwardly guiding the device from apoint of entry of the catheter through the tissue of the human body tothe target site within the human body during use of the device; saidfirst imaging element being configured to provide forward-directedimaging in a direction of the distal end of the elongate body to includethe distal tip of the tapered tip of the elongate body; and a removableintroducer needle disposed at an end-on aperture within the distal tipof the tapered tip of the elongate body during use of the device andbeing within said forward-directed imaging zone of said ultrasoundtransducer, said introducer needle and said device configured to beintroduced into said human body substantially simultaneously during useof the device, said introducer needle being configured under ultrasoundforward-directed imaging guidance, to puncture the human body proximateto said target site and to directly access and to puncture said targetsite including an internal body wall within the human body during use ofthe device via said forward-directed imaging zone of said ultrasoundtransducer.
 2. The device according to claim 1, wherein said elongatebody comprises a plurality of lumen and said first imaging elementcomprises a plurality of small ultrasound transducer elements arrangedin a substantially cylindrical housing disposed in said one longitudinallumen of said plurality of lumen.
 3. The device according to claim 2,wherein said substantially cylindrical housing has a circular face at adistal end thereof and said plurality of small ultrasound transducerelements are arranged in a parallel row along a diameter of saidcircular face.
 4. The device according to claim 2, wherein saidsubstantially cylindrical housing has an elliptical face at a distal endthereof and said plurality of small ultrasound transducer elements arearranged in a parallel row along one of a major and a minor axis of saidelliptical face.
 5. The device according to claim 2, wherein saidsubstantially cylindrical lousing has a flat face at a distal endthereof.
 6. The device according to claim 2, wherein said substantiallycylindrical housing has a rounded face at a distal end thereof.
 7. Thedevice according to claim 1, wherein said first ultrasound transducer isconfigured to operate at a frequency between 20 KHz and 300 MHz.
 8. Thedevice according to claim 7, wherein said first ultrasound transducer isconfigured to operate at a frequency less than 1 MHz to providetherapeutic treatment to the body during use of the device.
 9. Thedevice according to claim 7, wherein said first ultrasound transducer isconfigured to operate at a frequency above 1 MHz to provideforward-directed imaging within the body during use of the device. 10.The device according to claim 1, wherein said elongate body includes atleast one transverse lumen extending in a transverse direction across awidth of said elongate body, a second imaging element being disposed insaid at least one transverse lumen.
 11. The device according to claim 1,wherein said elongate body includes at least one transverse lumenextending in a transverse direction across a width of said elongatebody, a fiber optic imaging element being disposed in one of said atleast one longitudinal lumen and said at least one transverse lumen,said fiber optic imaging element being configured to provide imaging inone of a forward direction and of a transverse direction with respect tothe elongate body.
 12. The device according to claim 1, furthercomprising a microelectromechanical (MEMS) device operably attached tosaid first imaging element, said MEMS device being configured to permitmanipulation of said first imaging element to control a direction ofimaging provided by said first imaging element during use of the devicein addition to said forward-directed imaging.
 13. The device accordingto claim 1, further comprising a luer lock at the proximal end of theelongate body, said luer lock for connecting the introducer needle ofthe device to a syringe.
 14. The device according to claim 1, furthercomprising a retrieval instrument disposed within a second one of saidplurality of lumen, wherein said first imaging element is configured toprovide forward-directed imaging guidance for operation of saidretrieval instrument during use of the device.
 15. The device accordingto claim 14, said retrieval instrument including a biopsy needlereplacing said introducer needle.
 16. The device according to claim 14,said retrieval instrument including a bioptome.
 17. The device of claim1 being configured for intracardiac treatment via pericardial access,the pericardial access without entry of the device through a bloodvessel during use of the device.
 18. A device configured to be used inminimally invasive medical procedures, comprising: an elongate bodyhaving no exterior delivery catheter or sheath configured to facilitateentry of a catheter through skin tissue of a human body, the elongatebody having proximal and distal ends, said elongate body having atapered tip at the distal end being configured to be directly insertedinto a target site within the human body during use of the device, saidelongate body having at least one longitudinal lumen extending along alongitudinal axis thereof and further having a plurality of detentsalong an outer surface thereof; a first imaging element disposed in oneof said at least one longitudinal lumen, said first imaging elementhaving a proximal and a distal end, said first imaging element includinga first ultrasound transducer being located at an outer periphery of thetapered tip of the elongate body at the distal end of the at least onelongitudinal lumen, said first imaging element being configured forforwardly guiding the device from a point of entry of the catheter intothe tissue of the human body to the target site within the human bodyduring use of the device and to provide forward-directed imaging duringuse of the device in a direction from the distal end to include thetapered tip of the elongate body, a distal tip of the tapered tip of theelongate body being a most distal portion of the elongate body and beingforward of the first ultrasound transducer at the distal end; aremovable introducer needle disposed within an end-on aperture withinthe distal tip of the tapered tip of the elongate body and within afurther lumen extending through the elongate body, the introducer needlebeing within a forward-directed imaging zone of said ultrasoundtransducer during use of the device, said introducer needle and saiddevice configured to be introduced into said human body substantiallysimultaneously during use of the device, said introducer needle beingconfigured, under forward-directed ultrasound imaging guidance, topuncture an internal body wall proximate to said target site and todirectly access said target site within the human body via saidforward-directed imaging zone of said ultrasound transducer during useof the device; and an anchoring portion, said anchoring portion beingslidably movable along a length of said elongate body and being furtherconfigured to lock into place at one of said plurality of detents tosecure the device at a desired position within the human body during useof the device.
 19. The device according to claim 18, said anchoringportion having at least one suture hole.
 20. A device configured to beused in minimally invasive medical procedures, comprising: an elongatebody having no exterior delivery catheter or sheath, the elongate bodyconfigured to facilitate entry of a catheter through skin tissue of ahuman body, the elongate body having proximal and distal ends, saidelongate body having a tapered tip at the distal end, the elongate bodybeing configured to be directly inserted into a target site within thehuman body during use of the device and having at least one longitudinallumen extending along a longitudinal axis thereof, at least one of saidat least one lumen having a groove extending along a length thereof; aremovable introducer needle disposed within a forward-directed imagingzone of an ultrasound transducer, said introducer needle and said deviceconfigured to be introduced into said human body substantiallysimultaneously during use of the device, said introducer needle beingconfigured, under ultrasound forward-directed imaging guidance, topuncture a human body wall proximate to said target site and to directlyaccess said target site during use of the device, the introducer needlebeing disposed to extend from an end-on aperture of the tapered tip ofthe elongate body and being within said forward-directed imaging zone ofsaid ultrasound transducer during use of the device; and a first imagingelement, said first imaging element being disposed in a housing having aproximal and a distal end, said first imaging element including saidultrasound transducer at the distal end of said housing, said firstimaging element being located at an outer periphery of the tapered tipof the elongate body and being configured to provide forward-directedimaging in a direction from the distal end of the elongate body toinclude a tip of the tapered tip of the elongate body, the tip being amost distal portion of the elongate body and being forward of saidultrasound transducer at the outer periphery of the tapered tip of theelongate body at the distal end of the elongate body, the first imagingelement to provide imaging of forward navigation of the elongate bodyfrom a point of elongate body entry into the human body to a locationproximate the target site within the human body during use; said housinghaving a ridge extending along a length thereof from said proximal tosaid distal end, said housing being configured for slidable insertioninto said lumen having said groove, wherein said ridge on said housingjoins with said groove in said lumen to provide a secure fit of saidhousing into said lumen.
 21. The device of claim 20, further whereinsaid introducer needle is disposed in a second one of said at least onelumen, said needle being configured to facilitate access by the elongatebody to a portion of the human body during use of the device.
 22. Adevice configured to be used in minimally invasive medical procedures,comprising: an elongate body having no exterior delivery catheter orsheath configured to facilitate entry of a catheter through skin tissueof a human body, the elongate body having proximal and distal ends, saidelongate body having a tapered tip at the distal end being configured tobe directly inserted into a target site within the human body during useof the device and having a single longitudinal lumen extending along alongitudinal axis thereof; a needle, said needle being situated withinsaid single lumen in said elongate body, an end of said needle beingconfigured to extend from an end-on aperture of the tapered tip of theelongate body at a most distal tip of said elongate body and beingconfigured for puncturing a human body wall proximate to said targetsite and to directly access and to access said target site during use ofthe device, the distal tip and end-on aperture being a most distalportion of the elongate body; and a first imaging element, said firstimaging element being disposed in a housing having a proximal and adistal end, said first imaging element including a first ultrasoundtransducer at the distal end of said housing, said first imaging elementbeing located at an outer periphery of the tapered tip of the elongatebody being configured to provide a forward-directed imaging zone forforward-directed imaging during use of said needle in a direction fromthe outer periphery of the tapered tip of the elongate body at thedistal end to include the most distal tip of the elongate body and in adirection of said target site forward of said end-on aperture at saidmost distal tip during use of the device, said first imaging elementbeing situated within said single lumen in said elongate body and saiddistal end of said housing of said first imaging element being separatedfrom a proximal end of said needle by at least one buffer element, thefirst imaging element to provide imaging of forward navigation of theelongate body from a point of entry into the human body to the targetsite within the human body during use.
 23. The device of claim 22,wherein said elongate body further includes at least one channelextending from the proximal end of the elongate body to a point beyondthe at least one buffer element separating the first imaging element andthe needle.
 24. The device of claim 23, further including a Luer lock ata proximal end of the elongate body, the Luer lock being configured toattach to a syringe, said syringe being operably joined with said atleast one channel and being configured to permit one of a delivery offluid to said target site within the human body or a withdrawal of fluidfrom the target site via said needle during use of the device.
 25. Thedevice of claim 24, wherein said fluid configured to be delivered to thetarget site within the human body during use of the device includes oneof a drug, a saline solution, or a contrast medium.
 26. The device ofclaim 23, wherein said channel is configured to guide a guide wire fromthe proximal end of the elongate body to the distal end, said guide wirebeing configured to guide one of a second imaging element, a therapeuticdevice, an interventional device, or a diagnostic device to a targetsite within the human body during use of the device.